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Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial

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dc.contributor.author Suh, Chang-Hee
dc.contributor.author Yoo, Dae Hyun
dc.contributor.author Berrocal Kasay, Alfredo
dc.contributor.author Chalouhi El-Khouri, Elia
dc.contributor.author Cons Molina, Francisco Fidenci
dc.contributor.author Shesternya, Pavel
dc.contributor.author Miranda, Pedro
dc.contributor.author Medina-Rodriguez, Francisco G.
dc.contributor.author Wiland, Piotr
dc.contributor.author Jeka, Slawomir
dc.contributor.author Chavez-Corrales, Jose
dc.contributor.author Linde, Thomas
dc.contributor.author Hrycaj, Pawel
dc.contributor.author Abello-Banfi, Mauricio
dc.contributor.author Hospodarskyy, Ihor
dc.contributor.author Jaworski, Janusz
dc.contributor.author Piotrowski, Mariusz
dc.contributor.author Brzosko, Marek
dc.contributor.author Krogulec, Marek
dc.contributor.author Shevchuk, Sergii
dc.contributor.author Calvo, Armando
dc.contributor.author Andersone, Daina
dc.contributor.author Park, Won
dc.contributor.author Shim, Seung Cheol
dc.contributor.author Lee, Sang Joon
dc.contributor.author Lee, Sung Young
dc.date.accessioned 2019-07-04T17:00:18Z
dc.date.available 2019-07-04T17:00:18Z
dc.date.issued 2019
dc.identifier.uri https://hdl.handle.net/20.500.12866/6850
dc.description.abstract Objective: The aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks. Methods: In this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10, US-RTX, or EU-RTX alongside methotrexate. Efficacy endpoints included Disease Activity Score 28-joint count (DAS28) and American College of Rheumatology (ACR) response rates. Pharmacokinetics, pharmacodynamics, immunogenicity, and safety were also assessed. Results: Of 372 patients randomized to the study drug, 330 (88.7%) completed the second treatment course. Mean change from baseline to week 48 in DAS28-C-reactive protein was comparable in the CT-P10 and combined rituximab (US-RTX and EU-RTX) groups (− 2.7 and − 2.6, respectively). ACR20, ACR50, and ACR70 response rates at week 48 indicated no differences between groups (80.6%, 55.4%, and 31.7% vs. 79.8%, 53.9%, and 33.7% in the CT-P10 and combined rituximab groups, respectively). Similar improvements in the Health Assessment Questionnaire Disability Index and all medical outcomes in the Short Form 36-Item Health Survey, including physical and mental health, were seen in all groups. At week 48, antidrug antibodies were detected in 4.9%, 9.4%, and 8.6% of patients in the CT-P10, US-RTX, and EU-RTX groups, respectively. CT-P10 and rituximab displayed similar pharmacokinetic, pharmacodynamic, and safety profiles. Conclusion: CT-P10 was similar to EU-RTX and US-RTX in terms of efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and safety up to week 48. en_US
dc.language.iso eng
dc.publisher Springer
dc.relation.ispartofseries BioDrugs
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject mental health en_US
dc.subject human en_US
dc.subject adult en_US
dc.subject aged en_US
dc.subject female en_US
dc.subject male en_US
dc.subject Article en_US
dc.subject priority journal en_US
dc.subject controlled study en_US
dc.subject major clinical study en_US
dc.subject death en_US
dc.subject drug efficacy en_US
dc.subject multicenter study en_US
dc.subject drug safety en_US
dc.subject drug withdrawal en_US
dc.subject randomized controlled trial en_US
dc.subject lower respiratory tract infection en_US
dc.subject urinary tract infection en_US
dc.subject malignant neoplasm en_US
dc.subject C reactive protein en_US
dc.subject clinical outcome en_US
dc.subject pharmacodynamics en_US
dc.subject methotrexate en_US
dc.subject long term care en_US
dc.subject rheumatoid arthritis en_US
dc.subject antibody detection en_US
dc.subject upper respiratory tract infection en_US
dc.subject treatment duration en_US
dc.subject double blind procedure en_US
dc.subject immunogenicity en_US
dc.subject phase 3 clinical trial en_US
dc.subject rituximab en_US
dc.subject Short Form 36 en_US
dc.subject DAS28 en_US
dc.subject drug antibody en_US
dc.subject infusion related reaction en_US
dc.subject rhinitis en_US
dc.title Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1007/s40259-018-00331-4
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.01.05
dc.relation.issn 1179-190X


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